Study of Karenitecin (BNP1350) to Treat Malignant Melanoma - Tabular View

Tracking Information
First Received Date ^ICMJE	June 6, 2003
Last Updated Date	April 1, 2009
Start Date ^ICMJE	May 2002
Primary Completion Date	June 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 6, 2008)	Overall Response [ Time Frame: start of treatment until progressive disease ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00062491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 6, 2008)	Objective Tumor Response Rate [ Time Frame: Start of treatment to date of response ] [ Designated as safety issue: No ] Duration of Response [ Time Frame: Date of response to date of progressive disease ] [ Designated as safety issue: No ] Overall Survival [ Time Frame: Randomization to date of death from any cause ] [ Designated as safety issue: No ] Progression Free Survival [ Time Frame: Randomization to disease progression ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Study of Karenitecin (BNP1350) to Treat Malignant Melanoma
Official Title ^ICMJE	Phase 2 Trial of Karenitecin (BNP1350) in Patients With Malignant Melanoma
Brief Summary	The purpose of this study is to evaluate the safety and efficacy of Karenitecin (BNP1350) as a treatment for Malignant Melanoma.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Melanoma Neoplasm
Intervention ^ICMJE	Drug: Karenitecin (BNP1350)
Study Arms / Comparison Groups	Experimental: Karenitecin (BNP1350)
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	46
Completion Date	November 2005
Primary Completion Date	June 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Confirmed diagnosis of malignant melanoma Measurable disease Granulocytes ≥1,500/µl, Platelets ≥100,000/µl, Creatinine ≤ULN, Bilirubin ≤1.5 mg/dl, AST ≤2.5 x ULN No prior treatment with other camptothecin drug. ≥ 21 days since completion of prior chemotherapy, ≥6 weeks since prior Mitomycin-C ECOG Performance Status 0-1 Negative pregnancy test for female patients
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00062491
Responsible Party	BioNumerik (Chief Executive Officer), BioNumerik
Study ID Numbers ^ICMJE	KTN23106
Study Sponsor ^ICMJE	BioNumerik Pharmaceuticals, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	BioNumerik Pharmaceuticals, Inc.
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP